Update on KEYTRUDA Plus LYNPARZA Phase 3 Trial in Metastatic Nonsquamous NSCLC

The pharmaceutical company Merck, also known as MSD outside North America, has reported that its Phase 3 KEYLYNK-006 clinical trial did not achieve its primary goals for a new treatment approach. The trial was testing a combination of KEYTRUDA, an anti-PD-1 therapy, and LYNPARZA, a PARP inhibitor, as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The combination therapy did not outperform standard chemotherapy in terms of overall survival or progression-free survival, the two main measures of effectiveness.

The KEYLYNK-006 study was a significant undertaking, involving a large number of patients and a rigorous, two-phase process. It was designed to assess the efficacy of KEYTRUDA in tandem with chemotherapy, followed by either KEYTRUDA with LYNPARZA or additional chemotherapy. Despite the disappointing results, the safety profiles of the drugs used were in line with previous studies, and a comprehensive review of the data is ongoing.

Merck remains dedicated to improving outcomes for lung cancer patients and will continue to explore new combinations and treatments. Lung cancer is a pervasive issue, accounting for the majority of cancer-related deaths globally. In 2022, there were approximately 2.4 million new cases and 1.8 million deaths attributed to lung cancer worldwide. Non-small cell lung cancer constitutes about 80% of all lung cancer cases.

Merck's commitment to lung cancer research is evident through its extensive clinical trials program, which includes over 36,000 patients and nearly 200 trials globally. KEYTRUDA, an anti-PD-1 therapy, has been approved for various uses in the United States and is available for advanced disease treatment in over 95 countries.

KEYTRUDA works by enhancing the body's immune system to detect and combat tumor cells. It is a monoclonal antibody that targets the PD-1 pathway, stimulating the immune response against cancer cells. The drug is part of Merck's extensive immuno-oncology research program, which includes more than 1,600 trials across various cancers.

Despite the setback in the KEYLYNK-006 trial, the ongoing research and development efforts are crucial for advancing lung cancer treatment. Merck's global clinical development team, led by Dr. Gregory Lubiniecki, acknowledges the complexity of treating metastatic nonsquamous non-small cell lung cancer and expresses gratitude to the participants and investigators involved in the study. The pursuit of innovative treatments and combinations remains a priority in the fight against lung cancer.